Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist

Fertility Clinical Trial

— Avanti  

Official title:

The Effect of the Type of Ovarian Stimulation Protocol on PGD Results: a Prospective Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888744
• Other study ID #: 2010/010
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2013
• Last updated: June 27, 2013
• Start date: September 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: FAGG, Department R&D
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).

Description:

Patients will be randomized at the outpatient clinic in two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• = 39 years the day of oocyte retrieval

• BMI = 29

• cycle rank 1

• menstrual cycle 25-36 days

• PGD or preimplantation genetic screening (PGS) requested

• ICSI

• Single embryo transfer (SET) on day 5

Exclusion Criteria:

• Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria)

• Hormonal disturbances

• Endometriosis grade III and IV

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fertility
• Optimal Stimulation Protocol
• Reproductive Endocrinology

Intervention

Drug:
• GnRH agonist

• GnRH antagonist

• hP-hMG

• Human chorionic gonadotropin
induction of final oocyte maturation
• Progesterone

Locations

Country	Name	City	State
Belgium	Centre for Reproductive Medicine	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of day 3 embryos for biopsy available		up to 6 weeks	No
Secondary	Number of mature cumulus-oocyte complexes		up to 6 weeks	No
Secondary	clinical pregnancy rate		up to 9 months	No